Evaluation of the Hypoglycaemia Notification Device Hyposafe H02

Not Applicable

Terminated

Conditions: Diabetes Mellitus, Type 1

Interventions: Device: hyposafe H02

Registration Number: NCT02925676

Lead Sponsor: UNEEG Medical A/S

Brief Summary: To evaluate the technical performance of the hyposafe H02 during everyday activities and during insulin-induced hypoglycaemia, in addition to safety issues associated with the implantation and use of the hyposafe H02 in subjects with type 1 diabetes.

Detailed Description: While a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements and hence it is unreliable as a hypoglycaemia notification. Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe hypoglycaemia. However, some find these devices troublesome to use and are annoyed by the inaccuracy of the measurements and even after short-term use the coverage in subgroups of patients is as low as 50% of the time. Thus, there is a medical need for a reliable hypoglycaemia notification which is easy and convenient to use and with high sensitivity and high rate of positive prediction.

This clinical investigation is designed to evaluate the sensitivity and the positive predictive value of the Hyposafe H02 in subjects with type 1 diabetes during everyday activities and during insulin-induced hypoglycaemia. In addition, the investigation provides information regarding safety and usability of the device. This to verify that the Hyposafe H02 works as intended in subjects with type 1 diabetes before proceeding with a larger study in subjects with type 1 diabetes.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Informed consent obtained before any study related activities
Type 1 diabetes diagnosed at least five years prior to inclusion in the study
Impaired awareness and/or history of at least one severe hypoglycaemia within the preceding year

Exclusion Criteria

Severe cardiac disease
History of stroke or cerebral haemorrhage and any other structural cerebral disease
Active cancer or cancer diagnosis within the past 5 years
Uraemia defined as s-creatinine ≥ 3 times upper reference value
Liver disease defined as s-ALAT ≥ 3 times upper reference interval
Epilepsy
Use of antiepileptic drugs for any indication
Clinically important hearing impairment
Use of active implantable medical device including pacemaker and ICD-unit and cochlear implant
Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
Contraindications to the local anaesthetic used during implantation
Known or suspected abuse of alcohol or any other neuro-active substances
Infection at the site of device implantation
Any haemorrhagic disease
Females of childbearing potential who are pregnant or intend to become pregnant or are not using adequate contraceptive methods throughout the study
Performing extreme sport, including scuba diving (snorkel diving is allowed) or parachute jumping
Incapable of understanding the subject information or unlikely to complete the study for any reason
Operating MRI scanners
Operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military)
Working at broadcast stations for television or FM/DAB radio
Use of CGM or FGM with visible glucose measurements and activated glucose notifications
Involved in therapies with medical devices that deliver electrical energy into the area around the implant

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hyposafe H02	hyposafe H02	All subjects included are assigned to hyposafe H02-testing

Primary Outcome Measures

Name	Time	Method
Sensitivity	3 months	Number of spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated spontaneous hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG).
Positive Predictive Value	3 months	Number of validated spontaneous hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of notification from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG).

Secondary Outcome Measures

Name	Time	Method
Device Deficiencies	4 months	Total number of device deficiencies
Overall Sensitivity	3 months	Total number of hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of validated hypoglycaemic episodes. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).
Overall Positive Predictive Value	3 months	Total number of validated hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02. Validation was performed by self-measured blood glucose (SMBG) or plasma glucose (PG).
Sensitivity During Insulin-induced Hypoglycaemia	2 days	Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of insulin-induced hypoglycaemic episodes.
Positive Predictive Value for Insulin-induced Hypoglycaemia	2 days	Number of insulin-induced hypoglycaemic episodes detected by the hyposafe H02 compared to the total number of alerts from the hyposafe H02
Change in Impedance (kOhm) Over Time	start up and after 3 months	The EEG performance was measured as the impedance as a function of time. An impedance value below 5 kOhm is considered very good. Number of participants with impedance values below 5 kOhm and no change over time is reported.
Mean Glucose Level at the Time of a Hypoglycaemia Notification	3 months	Glucose levels were measured at the time of a hypoglycaemia notification during an outpatients settings (the spontaneous episodes) and during insulin-induced hypoglycaemia (the insulin-induced episodes)
User Satisfaction Based on Questionnaire	1 month	User satisfaction were evaluated as to whether the subjects wished to continue to use the device
Number of Participants With a Satisfactory EEG Quality Test	start up and after 3 months	The EEG quality test was performed twice in the study. At start up and at the end of the study. Evaluation was based on visual review of EEG of known phenomena and artefacts by an experienced EEG reviewer.
Development in Discomfort Over Time Based on Questionnaires	3 weeks, 7 weeks and 15 weeks after implantation (baseline)	Implant discomfort over time were evaluated at 3 time points; on average 3 weeks, 7 weeks and 15 weeks after implantation (baseline). Here the categories were converted into cardinal numbers: ranging from strongly agree=5 to strongly disagree=1 on the statement ''The implant has not caused discomfort in the past two days'.
Mean Number of Hours of Use Per Device	3 months	Mean number of hours of use per device is measured as recording time of device
Response to Hypoglycaemia Notification	3 months	Response to hypoglyceamia notifications measured as the participants were able to take preventive actions upon notification of hypoglycaemia in an outpatient settings (the spontaneous hypoglycemic episodes) and during insulin-induced hypoglycaemia
Alarm Fatigue Based on Questionnaire	3 months	The participants were given a questionnaire regarding their preferences for sensitivity and false alarms at the end of the study. Reporting are for preferences during the day.